Abstract��OBJECTIVE To develop a gradient supercritical fluid chromatography method for the separation of cinnarizine and its four related substances. METHODS Cinnarizine and its four related substances were separated on a Torus DIOL column (3.0 mm��100 mm,1.7 ��m) maintained at 40 �� with the mobile phase consisting of CO2 and methanol with 0.1% TFA-0.1% TEA at 1.5 mL��min-1, the detection wavelength was set at 230 nm and the back pressure was set at 1.38��107 Pa. RESULTS Cinnarizine and its four related substances were separated in 4.5 min with satisfying resolutions. Good linear relationships were established between the peak response and the concentration in the range of 2-20 ��g��mL-1 for each related substance (r>0.999 9) and the detection limits were 0.7-1.3 ng(S/N��3). Good linear relationships were established between the peak response and the concentration in the range of 0.05-1.0 ��g��mL-1 for cinnarizine (r=1.000 0). The spiked recovery of four related substances of cinnarizine was 98.0%-106.7%, and the RSD was 2.57%-4.44%(n=9). CONCLUSION The established method can be applied in the simultaneous determination of the related substances of cinnarizine and provide reference for the quality control.
�ų���, ��ޱ, ������, ������. ���ٽ�����ɫ������������е��й�����[J]. �й�ҩѧ��־, 2018, 53(18): 1603-1607.
ZHANG Chen-han, JIN Wei, ZHANG Shao-min, YANG Yong-jian. Determination of Related Substances in Cinnarizine by Supercritical Fluid Chromatography. Chinese Pharmaceutical Journal, 2018, 53(18): 1603-1607.
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